Transcranial Direct Current Stimulation (tDCS) with Cognitive Training to Reduce Impulsivity and Weight in Veterans with Obesity: A Clinical Trial

经颅直流电刺激 (tDCS) 结合认知训练可减少肥胖退伍军人的冲动和体重：一项临床试验

• 批准号: 10576261
• 负责人: SHALAMAR D SIBLEY
• 金额: --
• 依托单位: MINNEAPOLIS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576261
• 关键词: Anodes; Appetite Regulation; Bariatrics; Behavior; Behavior Therapy; Behavioral; Body Weight decreased; Brain; Cathodes; Cephalic; Characteristics; Chronic Disease; Clinic; Clinical; Clinical Trials; Combined Modality Therapy; Coupled; Coupling; Data; Decision Making; Devices; Disease; Double-blind trial; Eating; Eating Disorders; Enrollment; Executive Dysfunction; Exercise; Gambling; Gatekeeping; Group Structure; Habits; Health; Impulsive Behavior; Impulsivity; Individual; Intervention; Left; Life Style; Link; Measurable; Medical; Modality; Neuronal Plasticity; Non obese; Obesity; Outcome; Outcome Measure; Participant; Personality Traits; Pilot Projects; Population; Prefrontal Cortex; Protocols documentation; Randomized; Reaction Time; Recording of previous events; Refractory; Reporting; Research Personnel; Risk; Safety; Structure; Substance abuse problem; Task Performances; Testing; Therapeutic; Training; Training and Education; Veterans; Visit; Weight; analog; behavior change; cognitive training; computerized; design; executive function; follow-up; improved; interest; loss of control over eating; member; neuroregulation; noninvasive brain stimulation; novel; obesity treatment; pandemic disease; primary outcome; programs; randomized trial; recruit; success; transcranial direct current stimulation; weight loss program; weight maintenance

Impulsivity has been implicated in refractory obesity in bariatric and non-bariatric subjects (Sutin 2011, Filbey 2017, Gunstad 2017, Galioto 2016, Benard 2017). A healthy prefrontal cortex (PFC) may mitigate excess impulsivity effects on appetite regulation by providing critical executive function as a gate-keeper. Galioto et al found that executive function predicts weight loss success in structured medical weight loss programs (Galioto 2016). Given this background, improving prefrontal executive function to mitigate impulsivity would be valuable in obesity treatment. Cognitive training for improvement of executive function has not shown sufficient therapeutic promise. Similarly, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation modality, aimed at the PFC has been shown to be safe and well tolerated but not sufficiently effective as monotherapy. Combining prefrontal neuromodulation with cognitive training may be the novel, effective way forward for prefrontal neuromodulation as obesity therapy. Together, the two modalities enhanced executive function in non-obese subjects with executive function deficits in studies done by members of our team (Gilmore 2018). Thirty subjects with a clinical history of impulsive behavior were recruited for a sham-controlled protocol coupling the balloon analog risk task, a decision-making test, with five consecutive days of 25-minute tDCS treatments in which a 2-mA constant current was delivered over the dorsolateral PFC, anode over right PFC and cathode over the left PFC. Active tDCS stimulation coupled with cognitive training improved Balloon Analog Risk Task performance and reduced impulsivity on the Barratt Impulsiveness Scale. Reduction in risky decision making generalized to a second risk-related decision-making task, the Risk Task, which had not been utilized during the stimulated training sessions. Reduction in risky decision making persisted at the final two month follow up visit. This evidence supports our hypothesis that tDCS coupled with brain training can enhance executive function and improve clinical outcomes in individuals who suffer from impulsivity-related conditions. Neuroplasticity-based interventions such as this may provide novel treatment approaches to the challenging clinical problem of obesity. We have assembled a team of investigators with combined obesity and neuromodulation expertise to conduct a randomized double-blind trial of active vs. sham tDCS combined with cognitive training in subjects with obesity who report out-of-control eating and are enrolling in a structured group lifestyle coaching program. We will determine if tDCS coupled with cognitive training decreases impulsivity in these individuals with obesity. Our second aim is to evaluate whether tDCS coupled with executive function training enhances weight loss.

冲动与肥胖和非肥胖受试者的难治性肥胖有关（Sutin 2011， 菲尔贝 2017 年、冈斯塔德 2017 年、加里奥托 2016 年、贝纳德 2017 年）。健康的前额皮质 (PFC) 可以缓解 过度冲动通过提供作为看门人的关键执行功能来影响食欲调节。 Galioto 等人发现执行功能可以预测结构化医疗减肥中的减肥成功 计划（Galioto 2016）。鉴于这种背景，改善前额叶执行功能以减轻冲动 在肥胖症治疗中具有重要价值。改善执行功能的认知训练尚未显示出来 足够的治疗承诺。同样，经颅直流电刺激（tDCS）是一种非侵入性的治疗方法。 针对 PFC 的神经调节方式已被证明是安全且耐受性良好的，但还不够充分 作为单一疗法有效。 将前额神经调节与认知训练相结合可能是新颖、有效的前进方法 用于前额神经调节作为肥胖治疗。这两种方式共同增强了执行功能 我们团队成员进行的研究显示，非肥胖受试者存在执行功能缺陷（Gilmore 2018）。 招募了 30 名有冲动行为临床史的受试者进行假手术对照方案 将气球模拟风险任务（决策测试）与连续五天的 25 分钟 tDCS 结合起来 治疗中，在背外侧 PFC 上输送 2 mA 恒定电流，在右 PFC 上输送阳极 和左侧 PFC 上的阴极。主动 tDCS 刺激与认知训练相结合，改善 Balloon 巴勒特冲动量表上的模拟风险任务表现和冲动性降低。降低风险 决策推广到第二个与风险相关的决策任务，即风险任务，该任务尚未被 在刺激训练课程中使用。最后两场比赛中风险决策持续减少 月随访。这一证据支持我们的假设，即 tDCS 与大脑训练相结合可以 增强冲动相关个体的执行功能并改善临床结果 状况。诸如此类的基于神经可塑性的干预措施可能会提供新的治疗方法 具有挑战性的肥胖临床问题。 我们组建了一个由肥胖和神经调节专业知识组成的研究团队 对受试者进行主动与假 tDCS 结合认知训练的随机双盲试验 患有肥胖症并报告饮食失控并正在参加结构化团体生活方式辅导计划的人。 我们将确定经颅直流电刺激 (tDCS) 与认知训练相结合是否会降低这些患者的冲动性 肥胖。我们的第二个目标是评估 tDCS 与执行功能训练相结合是否可以增加体重 损失。